BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMATERIAL - CEMENT

    MDR report key: 9707759 · Received February 13, 2020

    Report

    Report Number
    1526439-2020-00545
    Event Type
    Injury
    Date Received
    February 13, 2020
    Report Date
    January 27, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 510K: THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PERU AS FOLLOWS: IT WAS REPORTED THAT ONE OF THE SCREWS PULLED OUT. WE DO NOT KNOW WHICH OF THE SCREWS PRESENTED THE PROBLEM (04 OF THE EXPEDIUM VERSE - DEPUY SPINE WERE PLACED). IT IS INDICATED THAT THE RELATIONS WITH THE DOCTOR ARE VERY DELICATE AND DOES NOT GIVE US MORE INFORMATION AND THERE WILL BE NO RETURN OF THE SAMPLE. DATE OF IMPLEMENTATION SURGERY: (B)(6) 2019. SCREWS THAT WERE IMPLANTED: MATERIAL: 199723850; LOT: 241988 - SCREW EXP. VERSE FENESTRADO 8X50 - 2 UNITS; MATERIAL: 199723840; LOT: 241986 - SCREW EXP. VERSE FENESTRADO 8X40 - 2 UNITS. CODE AND BATCH OF THE SCREW THAT PRESENTED FAILURE WAS NOT INFORMED. CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE FEN SCR 8.0X50 (PART#: 199723850, LOT#: 241988, QUANTITY UNKNOWN); 5.5 EXP VERSE FEN SCR 8.0X40 (PART#: 199723840, LOT#: 241986, QUANTITY UNKNOWN); UNKNOWN LOCKING SCREW (PART# 04.633.347, LOT#: 7489456, QUANTITY 1); UNKNOWN PLATE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) UNKNOWN BIOMATERIAL - CEMENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171122 UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT NDN MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention